Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation

NCT ID: NCT01606709

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to compare gene expression profiles in endometrial biopsies during the window of implantation after triggers of oocyte maturation using GnRH agonist or hCG and compared with their natural cycles in order to identify genes that may be dysregulated in GnRH agonist-triggered cycles.

The investigators also intend to evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

Detailed Description

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation (COH) which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. The use of a GnRH agonist for induction of final oocyte maturation in ovarian stimulation cycles utilizing GnRH antagonist for pituitary suppression has proven to be an effective method of preventing the risk of OHSS development.

Unfortunately, some studies, but not all, have also reported lower pregnancy rates in these cycles as compared to cycles using hCG trigger and this has been attributed to possible impaired endometrial receptivity.

The investigators intend to obtain endometrial biopsies collected from the same subject in a natural cycle and then a biopsy during either a GnRH agonist or hCG triggered stimulation. Expression profiles of mRNAs will first be screened using microarray technology. Relative levels of specific mRNAs that display altered expression in the GnRH-triggered samples, as assayed by microarray, will then be confirmed by real-time, quantitative reverse transcription/polymerase chain reaction (Q-PCR). The investigators shall also evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

Conditions

Endometrial Receptivity; Ovarian Hyperstimulation Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

GnRH agonist trigger

Induction of oocyte maturation with GnRH agonist

Group Type: EXPERIMENTAL

GnRH agonist

Intervention Type: DRUG

GnRH agonist 1mg one dose

hCG trigger

Induction of oocyte maturation with hCG

Group Type: ACTIVE_COMPARATOR

hCG

Intervention Type: DRUG

5,000 IU one dose

Interventions

GnRH agonist

GnRH agonist 1mg one dose

Intervention Type: DRUG

hCG

5,000 IU one dose

Intervention Type: DRUG

Other Intervention Names

leuprolide acetate,; lupron; Pregnyl

Eligibility Criteria

Inclusion Criteria

• Oocyte donors
• Ages between 21 and 33
• Normal baseline serum FSH < 10mIU/mL

Exclusion Criteria

• Hypothalamic dysfunction
• Smokers
• Baseline serum FSH ≥ 10mIU/mL

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 33 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Engmann

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence Engmann, MD, MRCOG

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

UCHC Division of Reproductive Endocrinology

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

11-168-1

Identifier Type: -

Identifier Source: org_study_id